“Approval of Foods from Genetically Modified Animals is Unjustifiably Slow”

The Los Angeles Times reported on concerns within the U.S. animal biotech industry and the chilling effect that will result if the government continues to turn its back on technologies in the pipeline. If the political process doesn’t allow the science-based regulatory process to work, we risk losing out on the benefits of this dynamic industry to other countries that are encouraging research and investment in this area.

Rosie Mestel of the Los Angeles Times writes:

Scientists have created a genetically modified milk that lacks a key protein involved in triggering allergies — an impressive technical feat that won plaudits in the biotechnology world.

But the development, published Monday in the journal Proceedings of the National Academy of Sciences, isn’t likely to lead soon to less-allergenic milk. The process for getting government approval to sell food derived from genetically engineered animals appears to be a hopeless logjam.

A salmon with designer DNA has been in regulatory limbo since the Food and Drug Administration concluded that the fish appeared to be safe and without environmental risk two years ago. The company behind the fish, AquaBounty Technologies, is still waiting for the final regulatory steps and a sign-off from the FDA.

A herd of so-called enviropigs engineered to digest plant phosphorus more efficiently — cutting feed costs as well as levels of polluting phosphorus in their manure — was euthanized this year because of funding difficulties and public wariness about genetically modified organisms. Cell and semen samples have been banked in cold storage until the regulatory climate and societal attitudes improve, according to the Canadian scientist who was in charge of the project.

Goats that produce a protein in their milk that can help fight diarrhea in young children are being moved from California to Brazil for commercial development in what some scientists see as a more biotechnology-friendly locale.

Scientists are working on a range of products in various stages of development, including virus-resistant chickens, meat with healthier fat and mastitis-resistant dairy cows that would require fewer antibiotics.

But the slow pace of progress on AquaBounty’s application has had a chilling effect on animal biotech efforts — which are conducted in academic laboratories and small companies, not by the multinational corporations that develop genetically modified plants. Efforts have been foundering for lack of funding, or moving overseas.

AquaBounty Technologies has enough money to survive until the end of January, said Ronald Stotish, president and chief executive of the company, based in Maynard, Mass.

In frustration, more than 50 scientists and biotechnology leaders sent a letter to President Obama last month asking him to urge the FDA to move forward on the AquaBounty salmon decision.

“There is much more at stake here than just a fish,” the scientists wrote.

UC Davis animal geneticist James Murray was one of those who signed the letter. He has engineered goats to produce the human protein lysozyme in their milk, which helps shape the bacterial flora in the gut and improve gastrointestinal health. Should his goats or someone else’s transgenic animals come before the FDA, “we need them to make a decision,” he said. “We need the political process to allow the science-based regulatory process to work.”